Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue.
Publication/Presentation Date
11-1-2021
Abstract
OBJECTIVES: The COMMENCE trial was conducted to evaluate the safety and effectiveness of an aortic bioprosthesis with novel RESILIA tissue (Edwards Lifesciences, Irvine, Calif). Reports of early noncalcific valve failure resulting from thrombosis or leaflet tears in other valves warrant careful evaluation of early valve performance.
METHODS: Patients underwent clinically indicated surgical aortic valve replacement with the Edwards Pericardial Aortic Bioprosthesis, Model 11000A (Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), single-arm, Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee; echocardiograms were analyzed by an independent core laboratory.
RESULTS: Between January 2013 and March 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years. Mean Society of Thoracic Surgeons predicted risk of mortality was 2.0% ± 1.8%. Follow-up duration was 3.7 ± 1.2 years, with a total of 2533 patient years of follow-up and a median follow-up of 4 years. Early all-cause mortality was 1.2%, thromboembolism 2.3%, all bleeding 1.0%, and major paravalvular leak 0.1%. One- and 4-year actuarial freedom from all-cause mortality was 97.7% (95% confidence interval, 96.5%-98.8%) and 91.9% (95% confidence interval, 89.7%-94.1%), respectively. At 4 years, New York Heart Association functional class improved compared with baseline in 63.0%, effective orifice area was 1.5 ± 0.5 cm
CONCLUSIONS: Safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue at 4 years are favorable. This novel tissue does not appear to result in unexpected early thrombosis events or noncalcific structural valve deterioration.
Volume
162
Issue
5
First Page
1478
Last Page
1485
ISSN
1097-685X
Published In/Presented At
Johnston, D. R., Griffith, B. P., Puskas, J. D., Bavaria, J. E., Svensson, L. G., & COMMENCE Trial Investigators (2021). Intermediate-term outcomes of aortic valve replacement using a bioprosthesis with a novel tissue. The Journal of thoracic and cardiovascular surgery, 162(5), 1478–1485. https://doi.org/10.1016/j.jtcvs.2020.01.095
Disciplines
Medicine and Health Sciences
PubMedID
32340804
Department(s)
Department of Surgery
Document Type
Article